Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis

Phase 4

Completed

Conditions: Relapsing-remitting Multiple Sclerosis

Interventions: Drug: Copaxone®
Drug: Rebif®

Registration Number: NCT00078338

Lead Sponsor: EMD Serono

Brief Summary: The primary objective of the study is to assess the clinical efficacy of Rebif® 44 microgram (mcg) three times per week compared with Copaxone® 20 milligram (mg) daily in subjects with relapsing Multiple Sclerosis.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 764

Inclusion Criteria

Be between 18 and 60 years of age
Have definite relapsing multiple sclerosis
Have had one or more relapses within the prior 12 months
Must be in a clinically stable or improving neurological state during the four weeks prior to Study Day 1
Expanded Disability Status Scale (EDSS) score from 0 to 5.5, inclusive
If female, she must either be post-menopausal or surgically sterilized; or use a hormonal contraceptive, intra uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study; and be neither pregnant nor breast-feeding
Confirmation that the subject is not pregnant must be established by a negative serum human chorionic gonadotropin (hCG) pregnancy test within 7 days of Study Day 1 and a negative urine pregnancy test on Study Day 1. A pregnancy test is not required if the subject is post-menopausal or surgically sterilized
Be willing and able to comply with the protocol for the duration of the study
Voluntarily provide written informed consent and, for USA sites only, a subject authorization under Health Insurance Portability and Accountability Act (HIPAA), prior to any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care

Exclusion Criteria

Have secondary progressive multiple sclerosis (SPMS) or primary progressive MS (PPMS)
Prior use of any interferon or glatiramer acetate
Have had treatment with oral or systemic corticosteroids or adrenocorticotrophic hormone (ACTH) within 4 weeks of Study Day 1 and within 7 days prior to the Day 1 magnetic resonance imaging (MRI)
Have a psychiatric disorder that is unstable or would preclude safe participation in the study.
Have significant leukopenia (white blood cell count < 0.5 times the lower limit of normal of the central laboratory) within 7 days of Study Day 1.
Have elevated liver function tests (alanine aminotransferase [AST], aspartate aminotransferase [ALT], alkaline phosphatase > 2.0 times the upper limit of normal [ULN] of the central laboratory, or total bilirubin > 1.5 times the ULN of the central laboratory) within 7 days of Study Day 1 or a history of hepatitis (including infectious or drug-induced)
Prior cytokine or anti-cytokine therapy within 3 months prior to Study Day 1
Prior use of immunomodulatory or immunosuppressive therapy (including but not limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide, mitoxantrone) within the 12 months prior to Study Day 1
Prior use of cladribine or have received total lymphoid irradiation
Have allergy or hypersensitivity to human serum albumin, mannitol, glatiramer acetate, natural or recombinant interferon-β, or any other components of the study drugs or gadolinium diethylenetriaminepentaacetic acid
Have taken intravenous immunoglobulin or any other investigational drug or taken part in any experimental procedure in the 6 months prior to Study Day 1.
Presence of systemic disease that might interfere with subject safety, compliance or evaluation of the condition under study (e.g. insulin-dependent diabetes, Lyme disease, clinically significant cardiac disease, human immunodeficiency virus [HIV], human T-cell lymphotrophic virus type I [HTLV-1])
Have had plasma exchange in 3 months prior to Study Day 1.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Copaxone®	Copaxone®	-
Rebif®	Rebif®	-

Primary Outcome Measures

Name	Time	Method
Time to First Relapse	Baseline up to 96 weeks	Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by subject and must be accompanied by at least 1 of the following: An increase of greater than or equal to (\>=) 1 grade in \>=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of \>=2 grades in 1 functional scale of the EDSS or an increase of \>= 0.5 or an increase of \>=1.0 in EDSS if the previous EDSS was 0. Time to first relapse was defined as the time in days from the date of first dose of study treatment to the date of first multiple sclerosis relapse. The mean time to first relapse for the 25th percentile and the 30th percentile during the 96-week treatment period was measured by Kaplan-Meier estimates and was reported.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (80): University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
Barrow Neurology Clinics
🇺🇸
Phoenix, Arizona, United States
Northwest NeuroSpecialists
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Tucson, Arizona, United States
University of California, Davis
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Sacramento, California, United States
Kaiser Permanente Neurology
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San Diego, California, United States
Advanced Neurology of Colorado, LLC
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Fort Collins, Colorado, United States
The MS Treatment Center at Griffin Hospital
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Derby, Connecticut, United States
Associated Neurologists of Southern Connecticut, P.C.
🇺🇸
Fairfield, Connecticut, United States
Neurological Center of South Florida
🇺🇸
Miami, Florida, United States
Harbourside Medical Plaza
🇺🇸
Tampa, Florida, United States
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University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States